Spots Global Cancer Trial Database for A Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+Obinutuzumab (GA101) in Participants With Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma (GADOLIN)
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Trial Identification
Brief Title: A Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+Obinutuzumab (GA101) in Participants With Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma (GADOLIN)
Official Title: An Open-Label, Multicenter, Randomized, Phase III Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+RO5072759 (GA101) in Patients With Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma
Study ID: NCT01059630
Conditions
Study Description
Brief Summary: This open-label, multicenter, randomized Phase III study will investigate the efficacy, safety, pharmacokinetics and pharmacoeconomics of obinutuzumab (RO5072759, GA101) combined with bendamustine followed by continued obinutuzumab treatment (maintenance monotherapy) compared with bendamustine alone treatment in participants with rituximab-refractory indolent Non-Hodgkin's lymphoma (iNHL). The end of study was defined to when safety follow-up for all patients had been completed (2 years' safety follow-up from last dose).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Southern Cancer Center, PC, Mobile, Alabama, United States
Dr. Donald W. Hill, MD, FACP, Casa Grande, Arizona, United States
Highlands Oncology Group, Rogers, Arkansas, United States
Kaiser Permanente - Bellflower, Bellflower, California, United States
Bay Area Cancer Research Group, LLC, Pleasant Hill, California, United States
Sharp Memorial Hospital, San Diego, California, United States
Georgetown University Medical Center Lombardi Cancer Center, Washington, District of Columbia, United States
Washington DC VA Med Center; Hematology, Washington, District of Columbia, United States
University of Florida, Gainesville, Florida, United States
University of Florida; Division of Hematology/Oncology, Gainesville, Florida, United States
Md Anderson Cancer Center Orlando, Orlando, Florida, United States
Rush Cancer Institute, Chicago, Illinois, United States
Quincy Medical Group, Quincy, Illinois, United States
Simmons Cancer Institute, Springfield, Illinois, United States
University of Iowa, Iowa City, Iowa, United States
Univ Louisville School of Med, Louisville, Kentucky, United States
New England Cancer Specialists, Scarborough, Maine, United States
Meritus Center for Clinical Research, Hagerstown, Maryland, United States
Capitol Comprehensive CA Care, Jefferson City, Missouri, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Hematology Oncology Assoc SJ, Mount Holly, New Jersey, United States
San Juan Oncology, Farmington, New Mexico, United States
The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc., Columbus, Ohio, United States
OHSU Knight Cancer Institute, Portland, Oregon, United States
Pacific Oncology, PC, Portland, Oregon, United States
OHSU Ctr for Health & Healing, Portland, Oregon, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, United States
Sanford Health System, Sioux Falls, South Dakota, United States
South Texas Inst of Cancer, Corpus Christi, Texas, United States
University of Texas M.D. Anderson Cancer Center, Houston, Texas, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Univ of Wisconsin Hosp & Clin, Madison, Wisconsin, United States
Lkh-Univ. Klinikum Graz, Graz, , Austria
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt., Salzburg, , Austria
Medizinische Universität Wien, Wien, , Austria
ZNA Stuivenberg, Antwerpen, , Belgium
AZ Groeninge, Kortrijk, , Belgium
CHU Ambroise Paré, Mons, , Belgium
Cross Cancer Institute, Edmonton, Alberta, Canada
British Columbia Cancer Agency, Kelowna, British Columbia, Canada
British Columbia Cancer Agency, Vancouver, British Columbia, Canada
Manitoba Cancer Care, Winnipeg, Manitoba, Canada
Moncton Hospital, Moncton, New Brunswick, Canada
Toronto East General Hospital; Main Pharmacy G Wing Basement, East York, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
CHUM-Hosp Notre Dame, Montreal, Quebec, Canada
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology, Montreal, Quebec, Canada
CHA Hopital de I enfant-Jesus, Quebec City, Quebec, Canada
Allan Blair Cancer Centre, Regina, Saskatchewan, Canada
Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika, Brno, , Czechia
Fakultni nemocnice Hradec Kralove, Hradec Kralove, , Czechia
I Interni klinika; Vseobecna fakultni nemocnice, Prague 2, , Czechia
Institut Bergonie; Hematologie Oncologie, Bordeaux, , France
Polyclinique Bordeaux Nord, Bordeaux, , France
Hopital Henri Mondor, Creteil, , France
CH Dijon, Dijon, , France
Centre d'oncologie-radiotherap, LeMans, , France
Hopital Claude Huriez, Lille, , France
Centre Leon Berard, Lyon, , France
Hopital Bon Secour, Metz, , France
CHU Hopital Saint Eloi, Montpellier, , France
Hopital Hotel Dieu Et Hme; Clinique Dermatologique, Nantes, , France
Hopital Necker, Paris, , France
Hopital Saint Louis; Dermatologie 1, Paris, , France
CHU Bordeaux, Pessac, , France
Centre Hospitalier Lyon Sud; Hematolgie, Pierre Benite, , France
Chu De Poitiers; Chu La Miletrie, Poitiers, , France
CHU de Reims, Reims, , France
Hopital Pontchaillou, Rennes, , France
Centre Henri Becquerel, Rouen, , France
Clinique Ste Anne, Strasbourg, , France
CHRU de; Maladies, Vasculaires, Vandoeuvre, , France
St. Johannes Hospital Duisburg, Duisburg, , Germany
Klinikum Frankfurt Höchst, Frankfurt am Main, , Germany
Asklepios Klinik St. Georg, Hamburg, , Germany
Universitaetsklinikum Leipzig, Leipzig, , Germany
Klinikum der Universitat Munchen, Campus Grobhadern;; Medizinische Klinik und Poliklinik III, München, , Germany
Schwarzwald-Baar Klinikum GmbH, Villingen-Schwenningen, , Germany
Azienda Ospedaliera Universitaria di Modena, Modena, Emilia-Romagna, Italy
Azienda Ospedaliera Univ, Ematologica, Udine, Friuli-Venezia Giulia, Italy
Azienda Ospedaliera Univ, Roma, Lazio, Italy
Universita La Sapienza, Roma, Lazio, Italy
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2, Milano, Lombardia, Italy
Irccs Policlinico San Matteo; Divisione Di Ematologia, Pavia, Lombardia, Italy
Azienda Ospedale San Giovanni, Torino, Piemonte, Italy
Ospedale Mauriziano Umberto I, Torino, Piemonte, Italy
Ospedale Vito Fazzi, Lecce, Puglia, Italy
Azienda Ospedaliero Univ, Catania, Sicilia, Italy
Azienda Ospedaliera Univ, Firenze, Toscana, Italy
VU MEDISCH CENTRUM; Dept. of Medical Oncology, Amsterdam, , Netherlands
Haga Ziekenhuis, Den Haag, , Netherlands
Albert Schweitzer Ziekenhuis, Dordrecht, , Netherlands
Universitair Medisch Centrum Groningen, Groningen, , Netherlands
Erasmus Mc - Daniel Den Hoed Kliniek; Medical Oncology, Rotterdam, , Netherlands
Erasmus MC, Rotterdam, , Netherlands
Regional Oncology Hospital, Irkutsk, , Russian Federation
Blokhin Cancer Research Center; Combined Treatment, Moscow, , Russian Federation
City Clin Hosp n.a. S.P.Botkin, Moscow, , Russian Federation
Russian Hema Res Ctr of RAMS, Moscow, , Russian Federation
Republican Clinical Hospital n.a. Baranov; Haematology, Petrozavodsk, , Russian Federation
Ryazan Regional Clinical Hosp, Ryazan, , Russian Federation
St. Petersburg State Medical University n.a. I.P. Pavlov; Hematology, transfusiology and transplanta, Saint-Petersburg, , Russian Federation
SRI of Hematology and Transfusiology, St. Petersburg, , Russian Federation
Clinica Universitaria de Navarra, Pamplona, Navarra, Spain
Hospital Univ. Nuestra Señora de Valme;, Sevillac, Sevilla, Spain
Hospital Universitario Basurto, Bilbao, Vizcaya, Spain
Hospital Universitario de la Princesa; Servicio de Hematologia, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Skånes University Hospital, Skånes Department of Onclology, Lund, , Sweden
Hematology Center; Karolinska Univ Hosp, Stockholm, , Sweden
Norrlands Uni Hospital; Onkologi Avd., Umeå, , Sweden
Onc Clin, Akademiska Sjukhuset, Uppsala, , Sweden
Universitaetsspital Basel; Onkologie, Basel, , Switzerland
Inselspital Bern; Universitätsklinik für medizinische Onkologie, Bern, , Switzerland
Kantonsspital Graubünden;Onkologie und Hämatologie, Chur, , Switzerland
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
Leicester Royal Infirmary, Leicester, , United Kingdom
Barts & London School of Med; Medical Oncology, London, , United Kingdom
Freeman Hospital, Newcastle upon Tyne, , United Kingdom
Singleton Hospital; Pharmacy Department, Swansea, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Genentech, Inc.
Role: STUDY_DIRECTOR
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